The Recall Desk
ModerateFDA (Drugs)·D-1301-2019·Announced 2019-05-22

DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is described as a precautionary measure due to potential contamination, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Unipharma, LLC is recalling 1,344 cartons of DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor. The affected product is identified by Lot 80054 and an expiration date of 10/31/20. The recall was initiated as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

The product was distributed nationwide and in Venezuela. Consumers should check their medicine cabinets for this specific lot and expiration date. If found, they should stop using the product and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
Manufacturer
Unipharma, Llc.
Affected units
1,344

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 80054 Exp. 10/31/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Unipharma, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →